RecruitingNAINTERVENTIONAL

First in Human Study for the Assessment of Safety and Initial Performance of the EAS1 System

This study is looking at a new medical device called the EAS1 system, which uses a special method called Irreversible Electroporation (IRE) to treat early-stage lung cancer. This is the very first time this system is being tested in people. The main goals are to check if the EAS1 system is safe to use and to see how well it works to destroy lung cancer cells. Participants will be adults with certain types of lung cancer who would otherwise be able to have surgery to remove their tumour. The study is open to both men and women aged 18 to 80 and will take place in several hospitals without a comparison group.

At a glance

Status

Recruiting

Phase

Sponsor

Snipe Medical

Enrolment target

Start

01 Nov 2024

Estimated completion

15 Jul 2025

Lung Cancer

What is this study about?

Imagine a new way to treat early-stage lung cancer that might be less invasive than traditional surgery. This study is exploring a new device called the EAS1 system. It uses a technique called Irreversible Electroporation (IRE). In simple terms, IRE uses electrical pulses to create tiny holes in cancer cells, which then causes those cells to die.

This is a 'first-in-human' study, meaning it's the very first time doctors are carefully testing this specific system in people. The main reason for this study is to make sure the EAS1 system is safe for patients and to get an early idea of how well it works against lung cancer. The researchers want to see if it can effectively destroy cancer cells in the lung.

The study is focusing on people who have certain types of lung cancer that are generally early-stage. These are people who would typically be candidates for surgery to remove their tumour. The hope is that this new method could offer another treatment option for patients in the future, potentially with advantages over existing approaches. However, it's important to remember that this is an early study, and more research will be needed to fully understand its benefits.

Key takeaways

This is a study for a new lung cancer treatment called EAS1.
It's the first time this system is being tested in people.
The study aims to check its safety and early results for early-stage lung cancer.
Participants must be adults with specific types of lung cancer who could also have surgery.
Regular check-ups and scans will monitor your health during the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over with a confirmed diagnosis of certain types of early lung cancer. Specifically, your tumour should be no larger than 30mm (about 1.2 inches) and located in a spot where there's at least 5mm of healthy lung tissue between it and the outer lining of your lung. You also need to be well enough to undergo lung surgery, as determined by a chest surgeon, and able to understand and agree to take part in the study.

There are also some reasons why you wouldn't be able to join. For example, if your tumour is too close to important structures like your main breathing tubes or major blood vessels, or if you have severe lung conditions like very bad emphysema or chronic obstructive pulmonary disease (COPD). You also can't join if you've recently had a serious lung infection, have certain heart conditions, or if doctors expect your life expectancy to be less than 12 months.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or older?
Do you have a diagnosis of early-stage lung cancer?
Is your lung tumour 30mm or smaller?
Has a thoracic surgeon said you are suitable for lung surgery?
Do you not have severe long-term lung conditions like very bad emphysema or COPD?
Is your tumour not touching main airways or blood vessels?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have a screening visit to check if you're eligible. This will involve reviewing your medical history, imaging scans (like CT or MRI), and some lung function tests. If you qualify and agree to join, you would then undergo the treatment with the EAS1 system. After the procedure, you'll have several follow-up visits, which will include regular check-ups and further imaging scans to monitor your health and how well the treatment worked. This allows the medical team to keep a close eye on your progress and any side effects. The total duration of your participation in the study, including all follow-up visits, will vary based on the study plan.

Potential risks and benefits

Like all medical procedures, particularly new ones, there are potential benefits and potential risks to consider. The main potential benefit is that this new EAS1 system could effectively treat your lung cancer with a potentially less invasive method. However, since this is a new treatment, there might be unknown side effects or complications. There's always a risk with any medical procedure, including bleeding, infection, or other issues related to the treatment itself. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Meir Medical Center
Verified postcode
Kfar Saba, Israel· Recruiting
University Hospital Complex of Salamanca
Verified postcode
Salamanca, Spain· Recruiting
Royal Brompton Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the EAS1 system?

The EAS1 system is a new medical device that uses electrical pulses to treat lung cancer cells, aiming to destroy them.

Who can join this study?

Adults aged 18 to 80 with early-stage lung cancer who are generally well enough for surgery and meet specific criteria.

Is this treatment available to everyone?

No, this is a research study, so the treatment is only available to participants who meet the specific eligibility requirements.

What does 'first-in-human' mean?

It means this is the very first time this particular treatment system is being tested in people to check its safety and initial effectiveness.

What are the main goals of the study?

The main goals are to find out if the EAS1 system is safe to use and to see how well it works to treat lung cancer.

How to find out more

Emily Ben Shlomo

emily.benshlomo@clalit.org.il 972523212687 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.